Catalog Number

01-6545TI

Brand Name

TMJ SYSTEM

Version/Model Number

01-6545TI

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P020016,P020016

Product Code

LZD

Product Code Name

Joint, Temporomandibular, Implant

Public Device Record Key

a405eb41-db86-43d9-8f0e-216b8dd7d67d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 17, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-